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Dear Helmut:
Totally agree with your suggestions given.
If we are talking about the formulation problem then why the same is not reflecting in the Fed study.
Also the results of the Fed pilot is similar to the Fed Pivotal.
Few of the results are also provided for your references and give us the final suggestions.
Fed Pivotal Study Results:
Fasting Pilot study Data:
Fasting Pivotal Study results:
Best Regards
Sam
Edited using BBCodes. Don’t use tabs in your posts. [Helmut]
Totally agree with your suggestions given.
- As per your earlier suggestions we have carried out Fed studies before the Fasting study.
- We were very happy when our Fed study meets the BE criteria.
- But totally depressed by seeming the results of the Fasting Data.
If we are talking about the formulation problem then why the same is not reflecting in the Fed study.
Also the results of the Fed pilot is similar to the Fed Pivotal.
Few of the results are also provided for your references and give us the final suggestions.
Fed Pivotal Study Results:
Dependent Ratio[%Ref] CI_90_Lower CI_90_Upper Power CV(%)
Ln(AUCINF_obs) 96 91 102 100 14.5
Ln(AUClast) 96 91 101 100 14.8
Ln(Cmax) 87.91 82 94 99.99 20.3Fasting Pilot study Data:
Dependent Ratio[%Ref] CI_90_Lower CI_90_Upper Power CV(%)
Ln(AUCINF_obs) 87.02 69.00 109.75 0.48 37.07
Ln(AUClast) 95.22 77.65 116.76 0.56 32.34
Ln(Cmax) 89.43 77.16 103.66 0.81 23.13Fasting Pivotal Study results:
Dependent Ratio[%Ref] CI_90_Lower CI_90_Upper Power CV(%)
Ln(AUCINF_obs) 98 92 103 100 18
Ln(AUClast) 98 92 103 100 18
Ln(Cmax) 79 74 84 100 21
Best Regards
Sam
Edited using BBCodes. Don’t use tabs in your posts. [Helmut]
Complete thread:
- Regulatory Query for study repeat sam 2013-07-27 07:50 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Repeats ElMaestro 2013-07-27 11:01
- Repeats sam 2013-07-27 11:18
- Repeats ElMaestro 2013-07-27 11:31
- Repeats sam 2013-07-27 11:57
- Repeats ElMaestro 2013-07-27 12:27
- Repeats sam 2013-07-27 12:45
- Bad science Helmut 2013-07-27 14:15
- Bad sciencesam 2013-07-28 09:05
- Posting style & incomplete information Helmut 2013-07-28 12:32
- Posting style & incomplete information sam 2013-07-29 06:46
- RTFM! Helmut 2013-07-29 07:53
- RTFM! sam 2013-07-29 08:40
- copy & paste error or what? Helmut 2013-07-29 11:14
- copy & paste error or what? sam 2013-07-29 12:46
- copy & paste error or what? Helmut 2013-07-29 11:14
- Calm down! jag009 2013-07-29 16:06
- RTFM! sam 2013-07-29 08:40
- Slightly off-topic: The wonders of pilot trials ElMaestro 2013-07-29 09:19
- Futility rule? Helmut 2013-07-29 12:16
- Futility rule? ElMaestro 2013-07-29 12:46
- Slightly off-topic: The wonders of pilot trials sam 2013-07-29 12:41
- PE of AUC? Helmut 2013-07-29 12:45
- PE of AUC? sam 2013-07-29 12:56
- EOD Helmut 2013-07-29 13:18
- PE of AUC? sam 2013-07-29 12:56
- PE of AUC? Helmut 2013-07-29 12:45
- Futility rule? Helmut 2013-07-29 12:16
- Posting style & incomplete information jag009 2013-07-29 16:32
- Posting style & incomplete information sam 2013-07-30 06:08
- RTFM! Helmut 2013-07-29 07:53
- Posting style & incomplete information sam 2013-07-29 06:46
- Bad science ElMaestro 2013-07-28 12:43
- Posting style & incomplete information Helmut 2013-07-28 12:32
- Bad sciencesam 2013-07-28 09:05
- Repeats ElMaestro 2013-07-27 12:27
- Repeats jag009 2013-07-27 22:17
- Repeats ElMaestro 2013-07-27 23:11
- Repeats sam 2013-07-27 11:57
- Repeats ElMaestro 2013-07-27 11:31
- Repeats sam 2013-07-27 11:18
- Regulatory Query for study repeat jag009 2013-07-27 22:29
- Regulatory Query for study repeat sam 2013-07-29 12:36
- Regulatory Query for study repeat luvblooms 2013-07-30 08:28
- More questions.. jag009 2013-07-30 16:53
- Regulatory Query for study repeat luvblooms 2013-07-30 08:28
- Regulatory Query for study repeat sam 2013-07-29 12:36
- Repeats ElMaestro 2013-07-27 11:01
Ing. Helmut Schütz